Studies have suggested that autologous mononuclear cells obtained from blood or bone marrow that are delivered into recently infarcted cardiac muscle or vessels may provide a therapeutic benefit as demonstrated by improved cardiac function. Prior art apheresis machines (designed to process blood into its components) can be adapted to extract and separate mononuclear cells from blood, but most are large and expensive. Also, to get enough cells from blood, either a large quantity of blood must be processed or the cells recovered from a smaller quantity of blood must be cultured to increase their number. Processing a large quantity of blood (and returning it to the patient) or culturing the cells is very time consuming and expensive (personnel time, capital equipment and floor space needs, etc.).
On the other hand, only a small amount of bone marrow (about 50 milliliters) needs to be aspirated to provide the amount of mononuclear cells required for a therapeutic effect. Extracting 50 ml of bone marrow is a relatively rapid procedure compared to processing blood. However, this small amount of bone marrow is not well adapted to be separated by prior art apheresis machines. None of the prior art apheresis machines wash the separated cells or provide a convenient way to provide a count estimate of the number/volume of cells that are made available for injection. In large-scale therapy investigations (large patient population, controls, dose and efficacy studies, etc.) or for an approved therapy, a certain degree of control or count of the number of cells injected may be required. Additionally, such studies or an approved therapy may likely be performed in many institutions and by many different physicians. Because the cells are normally delivered to the heart in the catheterization laboratory (“Cath lab”) environment, it is likely that providing equipment to enable Cardiologists/Cath lab personnel to perform the entire procedure would be the desirable.
Portable systems for separating cells from peripheral blood are described in U.S. Pat. Nos. 6,733,433 and 6,123,655. These systems are not suitable for use in a Cath lab environment because they are designed for single session use only. That is, because the portable system cannot keep track of cell samples obtained from more than one patient, the system requires a complete sterilization process and rest before use with a new patient.